AZD8529 Single Ascending Dose Study

AstraZeneca58 enrolled

Overview

This is a study to evaluate safety, tolerability, PK and PD effects of orally administered AZD8529 after single ascending doses

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

QUADRUPLE

Enrollment

Conditions

Healthy Volunteer

Interventions

AZD8529DRUG

Oral

PlaceboDRUG

Oral

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy male or female subjects aged 18 to 45 years (inclusive) on Day 1. Female subjects must be of non-child bearing potential. Exclusion Criteria: * Has received another new chemical entity (defined as a compound which has not been approved for marketing) or has participated in any other clinical study that included drug treatment within 3 months of the first administration of investigational prod * Plasma donation within one month of screening or any blood donation/blood loss \> 500mL during the 3 months prior to screening * Clinically relevant abnormalities in physical examinations, vital signs, ECG, clinical chemistry, hematology or urinalysis

Locations (1)

Research Site

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

To assess the safety and tolerability of single dose administration of AZD8529 when given orally to healthy male subjects and female subjects of non-childbearing potential.

Time frame: at each visit, at least daily, during the study.

Secondary Outcomes

To characterize the pharmacokinetics of AZD8529 in plasma and urine.

Time frame: Blood and urine samples will be taken during the study.

To asses the effect of food on the safety and pharmacokinetic profile of AZD8529.

Time frame: Safety assessments and blood and urine samples will be taken throughout the study.

Data from ClinicalTrials.gov

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